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Data updated: Mar 10, 2026

ZEVTERA

CEFTOBIPROLE MEDOCARIL SODIUM
Infectious Disease Approved 2024-04-03
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
1
Years on Market

Details

Status
Prescription
First Approved
2024-04-03
Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

ISTX
Active Ingredient: CEFTOBIPROLE MEDOCARIL SODIUM

ZEVTERA Approval History

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What ZEVTERA Treats

5 indications

ZEVTERA is approved for 5 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Staphylococcus Aureus Bloodstream Infection
  • Bacteremia
  • Infective Endocarditis
  • Acute Bacterial Skin and Skin Structure Infections
  • Community-Acquired Bacterial Pneumonia
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZEVTERA FDA Label Details

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Indications & Usage

FDA Label (PDF)

ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis , Adult patients with acute bacterial skin and skin structure infections (ABSSSI) , and Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP) . To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infec...

ZEVTERA Patents & Exclusivity

Exclusivity: Apr 2034

Exclusivity

NCE Until Apr 2029
GAIN Until Apr 2034
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA218275 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.